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临床试验/NCT07430007
NCT07430007
招募中
不适用

Effect of a Tailored Exercise and Dietary Lifestyle Intervention on Reducing Atrial Fibrillation Burden, Cardiac and Body Fat Mass in Overweight and Obese Patients. The MOVE-AF Ran-domized Clinical Trial

University of Eastern Finland4 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2025年10月30日最近更新:

概览

阶段
不适用
状态
招募中
入组人数
158
试验地点
4
主要终点
Atrial Fibrillation Burden

概览

简要总结

Atrial fibrillation (AF) is the most common cardiac arrhythmia and is strongly associated with obesity and excess body fat. Lifestyle interventions, including exercise and dietary modification, may reduce AF burden, but long-term randomized controlled trial evidence with objective AF burden assessment and advanced cardiac imaging is limited.

The MOVE-AF trial is a randomized controlled trial designed to evaluate whether a 12-month tailored exercise and dietary lifestyle intervention, compared with usual care, reduces atrial fibrillation burden and symptom severity and decreases cardiac and total body fat mass in overweight and obese adults with paroxysmal or persistent AF.

详细描述

Obesity is a major modifiable risk factor for atrial fibrillation and contributes to AF pathophysiology through systemic inflammation, autonomic imbalance, and adverse cardiac remodeling, including increased epicardial and atrial fat. Although exercise and weight reduction have been shown to improve AF-related outcomes, robust long-term randomized evidence integrating exercise, dietary intervention, objective AF burden monitoring, and cardiac magnetic resonance imaging is lacking.

MOVE-AF is a parallel-group, open-label randomized controlled trial enrolling 158 overweight or obese adults with symptomatic paroxysmal or persistent AF. Participants will be randomized 1:1 to receive either a tailored exercise and dietary lifestyle intervention plus usual care or usual care alone. The intervention consists of individualized guideline-based aerobic and resistance exercise combined with dietary counseling aimed at reducing body fat mass.

Main outcomes include AF burden assessed using continuous ambulatory rhythm monitoring, AF symptom severity assessed using validated questionnaires, and cardiac and total body fat mass assessed by cardiac MRI and body composition analysis. Secondary outcomes include cardiorespiratory fitness, muscle strength, cardiac autonomic nervous system function, cardiac remodeling, healthcare utilization, cost-effectiveness, and genetic risk modification of intervention effects.

The study is conducted in accordance with the Declaration of Helsinki and applicable regulatory requirements. All participants will provide written informed consent before enrollment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18-75 years
  • Body mass index (BMI) ≥27 kg/m²
  • Documented atrial fibrillation (paroxysmal or persistent)
  • Ability to participate in exercise training and follow study procedures
  • Access to a smartphone or device enabling rhythm monitoring
  • Provides written informed consent

排除标准

  • Permanent atrial fibrillation
  • Unstable angina pectoris or acute coronary syndrome within the past 3 months
  • Participation in other lifestyle or drug weight reduction trials
  • Significant left ventricular dysfunction (ejection fraction \<30%)
  • Severe valvular heart disease or planned cardiac surgery
  • Severe heart failure (NYHA class IV) or severe angina (CCS class IV)
  • Unstable coronary artery disease or recent myocardial infarction
  • Severe pulmonary disease limiting exercise capacity
  • Active malignancy
  • Autoimmune or systemic inflammatory diseases

研究组 & 干预措施

12-Month Tailored Exercise and Dietary Lifestyle Intervention

Experimental

Participants receive standard clinical care for atrial fibrillation plus a 12-month tailored lifestyle program including individualized aerobic exercise, muscle strength training, and dietary counseling.

干预措施: Tailored Exercise and Dietary Lifestyle Program (Behavioral)

Usual Clinical Care

Other

Participants receive standard clinical care for atrial fibrillation without any structured exercise or dietary lifestyle intervention.

干预措施: Usual Clinical Care (Other)

结局指标

主要结局

Atrial Fibrillation Burden

时间窗: 12 months

Total atrial fibrillation burden measured by continuous rhythm monitoring over the intervention period. Unit of Measure: Percentage of time in atrial fibrillation (%)

次要结局

  • Cardiac Fat Mass(12 months)
  • AF Symptom Severity(12 months)
  • Body Fat Mass(12 months)
  • Six-Minute Walk Test (6MWT)(12 months)
  • AF-Related Quality of Life (AFEQT Overall Score)(12 months)
  • Cost-effectiveness analysis(36 months)
  • Left Atrial Volume(12 months)
  • Cardiac autonomic nervous system function(12 months)
  • Peak Oxygen Uptake (VO₂peak)(12 months)
  • Left Atrial Volume Index(12 months)
  • Left Atrial Strain(12 months)
  • Left Ventricular Ejection Fraction(12 months)
  • E/e' Ratio(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jari Laukkanen

Professor, cardiologist

University of Eastern Finland

研究点 (4)

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